(a) Each Producer shall participate in a Stewardship Plan. Each Producer must: (1) operate, individually or jointly with other Producers, a Stewardship Plan approved by the Director; or (2) enter into an agreement with a Stewardship Organization to operate, on the Producer's behalf, a Stewardship Plan approved by the Director.
(b) Each Stewardship Plan must be approved by the Director before the entity administering the plan starts collecting Unwanted Covered Drugs. Once approved, each Stewardship Plan must have prior written approval of the Director for proposed changes as described under Section 2212.
(c) By six months after the effective date of this Division I or by six months after a Producer starts sale of a Covered Drug in the City, a Producer must notify the Director in writing of the Producer's intent to participate in a Stewardship Plan, or to form a new Stewardship Plan.
(d) By six months after the effective date of this Division I, or by six months after a retailer whose label appears on a Covered Drug or the Covered Drug's packaging starts selling the Covered Drug in the City, or by six months after a Covered Drug repackaged by Repackager is first sold in the City, and, thereafter, upon request from the Director, a retailer or Repackager whose label appears on a Covered Drug or the Covered Drug's packaging must provide:
(1) written notification as to whether the Manufacturer from whom the retailer or Repackager obtains the Covered Drug has provided its notice of intent to participate; and
(2) the contact information of the Manufacturer from whom the retailer or Repackager obtains the Covered Drug, including the telephone number, mailing address and email address of the retailer's or Repackager's point of contact at the Manufacturer.
(e) A Producer, either individually or jointly with other Producers, shall:
(1) By nine months after the effective date of this Division I, or nine months after starting sale of a Covered Drug in the City, identify in writing to the Director a Stewardship Plan operator, including the operator's telephone, mailing address and email contact information, that is authorized to be the official point of contact for the Stewardship Plan;
(2) By nine months after the effective date of this Division I, or nine months after starting sale of a Covered Drug in the City, notify all Retail Pharmacies and law enforcement agencies in the City of the opportunity to participate as a drop-off site in accordance with Sections 2205 of this Division I and provide a process for forming an agreement between the Stewardship Plan and interested Collectors; and annually thereafter, make the same notification to any nonparticipating or new Retail Pharmacies in the City;
(3) By one year after the effective date of this Division I, or one year after starting sale of a Covered Drug in the City, submit a proposed Stewardship Plan as described in Section 2204 to the Director for review;
(4) Within three months after the Director's approval of the Stewardship Plan, operate or participate in the Stewardship Plan in accordance with this Division I;
(5) At least every four years after the Stewardship Plan starts operations, submit an updated Stewardship Plan to the Director explaining any substantive changes to components of the Stewardship Plan required in Section 2204. The updated Stewardship Plan shall be accompanied by the plan review fee in accordance with Section 2215 of this Division I. The Director shall review updated Stewardship Plans using the process described in Section 2210 of this Division I; and
(6) Pay all administrative and operational costs and fees associated with its Stewardship Plan.
(f) A Producer, either individually or jointly with other Producers, may:
(1) Enter into contracts and agreements with Stewardship Organizations, other service providers, or other entities as necessary, useful or convenient to carry out all or portions of their Stewardship Plan;
(2) Notify the Director of any Producer selling Covered Drugs Manufactured by that Producer or group of Producers in the City that is failing to participate in a Stewardship Plan; and
(3) Perform any other functions as may be necessary or proper to carry out the Stewardship Plan and to fulfill any or all of the purposes for which the plan is organized.
(g) After the first full year of participation in a Stewardship Plan, a Producer or group of Producers may notify the Director in writing of intent to form a new Stewardship Plan, and identify a plan operator, including the plan operator's telephone, mailing address, and email contact information, that is authorized to be the official point of contact for the proposed new Stewardship Plan. Within three months of such notification, the Producer or group of Producers shall submit a proposed Stewardship Plan as described under Section 2204 to the Director for review.
(h) The Director may, on a case-by-case basis, approve in writing requests for extensions of time for the submission dates and deadlines in this Section 2203.
(i) The Director may audit the records of a Producer, group of Producers, or Stewardship Organization related to a Stewardship Plan or request that the Producer, group of Producers, or Stewardship Organization arrange for the Director to inspect at reasonable times a Stewardship Plan's or a Collector's facilities, vehicles, and equipment used in carrying out the Stewardship Plan.